NCT02719210

Brief Summary

All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 6, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

February 17, 2016

Last Update Submit

December 4, 2018

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (2)

  • Transplant free Survival.

    7 days

  • Transplant free survival

    30 days

Secondary Outcomes (10)

  • Survival after liver transplant with or without High Volume Plasma Exchange.

    30 days post procedure

  • Incidence of organ dysfunction (other than liver and Central Nervous System).

    30 days

  • Number of organs (other than liver and CNS) affected in children with organ dysfunction.

    30 days

  • Incidence of High Volume Plasma Exchange related complications- Major/Minor.

    within 1 month

  • Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.

    0 day

  • +5 more secondary outcomes

Study Arms (2)

High Volume Plasma Exchange with Standard Treatment

EXPERIMENTAL
Biological: High Volume Plasma Exchange

Standard Treatment

ACTIVE COMPARATOR

Standard Treatment is defined as anti raised Intra-cranial pressure 1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). 2. Mannitol 3. Hypertonic 3% Saline

Drug: Hypertonic 3% salineDrug: MannitolDevice: Elective positive pressure ventilation

Interventions

High Volume Plasma ExchangeBIOLOGICAL
High Volume Plasma Exchange with Standard Treatment
Hypertonic 3% salineDRUG
Standard Treatment
MannitolDRUG
Standard Treatment
Elective positive pressure ventilationDEVICE
Standard Treatment

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.

You may not qualify if:

  • Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
  • Refusal of consent or assent (annexure 3)
  • Liver resections with liver failure
  • Patients with clinical suspicion of irreversible brain injury
  • Patients with acute kidney injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Sodium ChlorideMannitol

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Dr Arti Pawaria, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

March 25, 2016

Study Start

January 1, 2016

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

December 6, 2018

Record last verified: 2018-05

Locations

IN(1)